Letter from Medicines Sans Frontieres to Pascal Lamy on the U.S.'s
Bilateral and Multilateral Free Trade Agreements and Access to Healthcare

March 5, 2003

Dear Mr Lamy,

In view of the forthcoming WTO TRIPS Council meeting next week, we would
like to bring some critical issues to your attention.

The adequate protection of public health demands that WTO Members be
permitted to give full effect to the letter and spirit of the Doha
Declaration on TRIPS and Public Health ("Doha Declaration") in their
domestic and/or regional legislation.

MSF was therefore very pleased to see the Communication of the EC to the
last TRIPS Council, dated 21st November 2003 in which the EC states
"...the EC reiterated its commitment to fully take the Doha Declaration
into account into their trade policy, in particular in the context of
technical assistance for the implementation of the TRIPS Agreement... [and
calls upon] all technical assistance providers, and in particular
multilateral organisations, to join them in making this commitment, and
to fully integrate the Doha Declaration in their policies and practices."

However there are several bilateral and regional agreements that include
provisions that threaten the implementation of the Doha Declaration
including the effective use of the August 30th decision.

For example the Central American Free Trade Agreement (CAFTA) recently
agreed between the United States and Costa Rica, El Salvador, Guatemala,
Honduras, and Nicaragua includes clear examples of "TRIPS plus"
provisions. Under CAFTA, parties will be obliged to extend
pharmaceutical patent terms beyond the 20 years required in WTO rules;
prevent the marketing approval of generic medicines if there is a
patent; and grant additional exclusive marketing rights by prohibiting
drug regulatory agencies to use original pharmaceutical test data for
the registration of generic medicines, a restriction referred to as
"data exclusivity."

Our deepest concern is with one provision (Article 15.10(3)(a)) that
states that a generic producer may not obtain marketing approval of a
product covered by a patent "during the term of that patent, unless by
consent or acquiescence of the patent owner." Even if a license on the
patent is granted to a generic producer/importer, the patent owner
appears to be able to prevent marketing approval of its equivalent
medicine. This means that even with a compulsory license the relevant
generic medicine cannot be marketed because the drug regulatory
authorities are prohibited from granting it a marketing approval. This
provision would appear to prevent the effective use of compulsory
licensing including the August 30th mechanism.

If this were the case and if CAFTA comes into force, then, the Doha
Declaration and the August 30th Decision could be nullified for the
parties to the Agreement at a single stroke.

Similar provisions, all of which exceed WTO requirements, are also found
in the draft FTAA agreement. CAFTA is only one of a number of Free Trade
Agreements that the United States has pursued or is pursuing. MSF is
concerned that further proliferation of TRIPS plus provisions in such
agreements may jeopardise the progress that has been made on access to
medicines. This may have enormous consequences for the health and life
of millions of people. This is particularly so given the deadline of 1st
January 2005 after which pharmaceutical product patent protection has to
be provided by all non-Least Developing Country Members.

Therefore, we request that you follow up on your commitment by raising
the concerns about the threats of TRIPS plus provisions in bilateral and
regional trade agreements to the full implementation of the Doha
Declaration and the August 30 th decision in the TRIPS Council.

We also ask you to raise these concerns with your US counterparts and to
urge the US to abandon their pursuit of TRIPS plus provisions that
negatively affect access to medicine in developing countries.

We would be most willing to meet with you to discuss how further
progress can be made in this area and to update you on developments on
access to medicines in the countries where we work.